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During the pivotal phase 3 clinical trials of mRNA COVID-19 vaccines, several cases of facial paralysis were observed in the vaccine groups (7 of 35 654) compared with 1 case among people who received placebo (1 of 35 611).1,2 Although a causal relationship could not be established from clinical trials, the US Food and Drug Administration recommended monitoring vaccine recipients for facial paralysis. We thus explored this potential safety signal through a disproportionality analysis using the World Health Organization pharmacovigilance database, VigiBase.
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Accepted for Publication: March 31, 2021.
Published Online: April 27, 2021. doi:10.1001/jamainternmed.2021.2219
Corresponding Author: Charles Khouri, PharmD, Pharmacovigilance Department, University Grenoble Alpes and Grenoble Alpes University Hospital, Centre Regional de Pharmacovigilance, CHU Grenoble Alpes, CS 10217, 38043 Grenoble Cedex 9, France (email@example.com).
Author Contributions: Dr Khouri had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Mr Renoud and Dr Khouri served as co–first authors.
Concept and design: Khouri, Revol, Perez, Cracowski.
Acquisition, analysis, or interpretation of data: Renoud, Khouri, Lepelley, Roustit, Cracowski.
Drafting of the manuscript: Renoud, Khouri.
Critical revision of the manuscript for important intellectual content: Khouri, Revol, Lepelley, Perez, Roustit, Cracowski.
Statistical analysis: Renoud, Khouri, Revol, Perez.
Administrative, technical, or material support: Renoud.
Supervision: Khouri, Lepelley, Cracowski.
Conflict of Interest Disclosures: None reported.
Disclaimer: The information does not represent the opinions of the Uppsala Monitoring Centre or the World Health Organization.
Additional Information: We thank VigiBase for giving us access to the data. The data supplied to VigiBase come from a variety of sources, and the likelihood of a causal relationship is not the same in all reports.
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